Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial

The trial will be composed of two cohorts:

• Patients treated with up-front rotational atherectomy
• Patients in whom atherectomy is not planned

Randomization to either cutting balloon angioplasty or intravascular lithotripsy will occur as follows in the 2 cohorts:

• After rotational atherectomy is safely completed In the rotational atherectomy arm
• After safe and successful wire crossing in patients in whom atherectomy is not planned.

The trial is designed to demonstrate non-inferiority between cutting balloon angioplasty and intravascular lithotripsy in each cohort with regards to the primary endpoint of post-procedural stent area as measured by intravascular imaging at the site of maximal calcification.

Inclusion criteria

• 1. Subject is > 21 years old 2. Subject with an indication for PCI for the treatment of a) stable coronary artery disease; b) unstable angina; or c) NSTEMI with evidence of down-trending biomarkers 3. Subject is willing and able to provide informed written consent Angiographic Inclusion Criteria

• The target lesion is a de novo native coronary lesion
• The target vessel is a native coronary artery with either:

• A stenosis > 70%; or,
• A stenosis > 50% and <70% with evidence of ischemia via either positive stress test, FFR value < 0.80 or RFR/iFR/DFR value < 0.89
• The reference diameter of the target vessel is > 2.5mm and < 4.0 mm at the lesion site
• The target lesion has evidence of significant calcium at the lesion site defined either as,

• The presence of radiopacities involving both sides of the arterial wall > 5mm and involving the target lesion on angiography
• the presence of > 270o arc of superficial calcium on intravascular imaging with a length > 5mm or the presence of 360o arc of superficial calcium

Exclusion criteria

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• Patient is pregnant
• Patient is actively participating in another clinical trial
• Known LVEF < 25%
• Ongoing Non-STEMI with rising biomarkers
• Cardiogenic shock or requirement for mechanical/pharmacologic hemodynamic support
• Planned use in the randomized lesion of a bare metal stent or non-stent treatment only
• Patient has a known allergy to contrast which cannot be adequately pre-treated
• Patient has a history of bleeding or coagulopathy and is unable to receive blood transfusion if needed
• Patient presents with STEMI
• Patient is unable to tolerate dual anti-platelet therapy
• Patient has suffered a recent cerebrovascular event (stroke/TIA) within last 30 days

Angiographic Exclusion Criteria

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• Presence of large thrombus in the target vessel
• Inability to pass coronary guidewire across the lesion
• The target vessel has excessive tortuosity (Defined as presence of 2+ bends > 90o or 3+ bends > 75o) or other anatomic considerations that precludes intravascular imaging
• The target lesion is within a coronary artery bypass graft
• The target lesion involves a bifurcation lesion in which either a 2-stent strategy is planned or both branches are planned for calcium modification
• Coronary artery disease that requires surgical revascularization
• Angiographic or imaging evidence of dissection in the target vessel prior to randomization
• Investigator feels there is not equipoise regarding the treatment strategy